The Retain Your Brain Health Study (RetainYourBrain.com)

Retain Health, Inc

Status: Completed

Conditions: Alzheimer Disease; Healthy Participants; Brain Health; Dementia

Treatments: Behavioral: Alzheimer Disease Education; Behavioral: Brain Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06027320

20216157

4R44AG071416 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to test a cell phone-based online program that provides Alzheimer's risk assessments and memory tests over a 6-month period. The main question it aims to answer is whether online software can help reduce the risk of Alzheimer's disease (AD) through digital education and tracking.

Participants will visit RetainYourBrain.com to answer questions about their risk factors for AD and take online word recall and card game cognitive tests. Researchers will track progress over time and compare different strategies of Alzheimer's education to see if it is possible to protect brain health, reduce Alzheimer's risk, and improve memory function.

Full description

Alzheimer's disease (AD) is a public health crisis with few effective treatments. Most people are unaware that AD begins in the brain decades before the first symptoms of memory loss begin. That leaves a lot of time for people to learn their individual risk factors for AD and cognitive decline and take memory assessment screening tests in an effort toward the prevention or delay of dementia. To reach a growing at-risk population, mobile health technologies accessible via cell phone can fill an unmet need due to their accessibility and cost-effective delivery of care. Online education and text messaging have proven to be effective methods of reducing risk for a variety of chronic conditions, including cardiovascular disease and diabetes, which are both key drivers of AD risk.

The investigators created a cell phone-based online software application to provide automated, individualized monitoring and education at broad scale. The goal of the software is to function as a digital therapeutic to identify individual risk factors, assess memory and cognitive function over time, and provide education to people with a family history of AD. The system maintains bi-directional communication via text message to verify participant engagement.

Potential participants who visit our study website (www.RetainYourBrain.com) will be directed to answer questions assessing eligibility criteria. Participants who are eligible are asked to electronically sign an informed consent form, complete baseline assessments, and take online word recall and card game cognitive tests. Participants will then be randomized to one of two groups using different strategies for AD risk assessment education. Researchers will track progress over six months and compare different strategies of education to determine if it is possible to protect brain health, reduce Alzheimer's risk, and improve memory function.

Enrollment: 992 patients

Sex: All

Ages: 53 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• be at least 53 years of age
• have a family history of Alzheimer's Disease (AD)
• have a compatible phone/device (phone allowing text messages and with internet access, and/or tablet device with the same capabilities)
• a minimum of one of the following risk factors: body mass index (BMI) of < 25 kg/m2, history of pre-diabetes/diabetes, high blood pressure, high cholesterol, smoking, low physical activity, low fish intake (< 3 times per month), high alcohol intake (< 7 servings per week for a women and <14 servings a week for men), diagnosed with mild or moderate depression.

Exclusion criteria

• have a diagnosis of dementia due to AD
• other dementia
• women who are currently pregnant or who plan on becoming pregnant in the next 6 months
• BMI <18.5 kg/m2
• consuming >35 alcoholic drinks/week for men or >28 alcoholic drinks/week for women
• severe depression (PHQ-9 score of more than 15)
• current treatment for cancer
• diagnosis of Parkinson's disease, amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal disorders, multiple sclerosis, or other neurodegenerative disease
• current treatment for an eating disorder
• currently prescribed insulin for type I or II diabetes
• inability to give informed consent or complete identity verification
• participating in another AD trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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992 participants in 2 patient groups

Brain Health Education Arm

Experimental group

Description:

Subjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication.

Treatment:

Behavioral: Brain Health Education

Alzheimer Disease Education Arm

Other group

Description:

Subjects will receive an Alzheimer's risk assessment, memory testing, and general education about Alzheimer's disease, in addition to text message communication.

Treatment:

Behavioral: Alzheimer Disease Education